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510(k) Data Aggregation

    K Number
    K191436
    Device Name
    Saalio
    Manufacturer
    Saalmann medical GmbH & Co. KG
    Date Cleared
    2019-10-18

    (141 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Saalmann medical GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tap water iontophoresis device intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
    Device Description
    The Saalio® unit is a therapeutic device for the treatment of primary focal hyperhidrosis, i.e. excessive sweating of defined body parts. The control device is powered by an external power supply and connected to two electrodes by means of two single cables. The electrodes are brought in contact with the body parts to be treated via a conductive water passage, thus closing the electric circuit. The control device conducts direct current or pulsed direct current) through the body parts. Depending on the body part to be treated, different electrodes are used. For the treatment of hands and feet, two generous sized silicone electrodes are placed into two travs filled with tap water. The electrodes are covered with foam inserts so as to prevent the body parts to be treated making direct contact with the electrodes. For the treatment of armpits, two smaller silicone electrodes are inserted into sponge pads which have been saturated with tap water. These are then tucked under the armpits for the duration of the treatment. It must be insured that the sponge material is always sufficiently saturated.
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